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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceJUVEDERM VOLUMA XC
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP110033
Supplement NumberS004
Date Received01/23/2014
Decision Date02/21/2014
Product Code LMH 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT00978042
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
USE OF A TEMPORARY WAREHOUSE FOR THE STORAGE OF RAW MATERIALS, PACKAGING ITEMS, AND FINISHED PRODUCTS.
Post-Approval StudyShow Report Schedule and Study Progress
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